In a major relief to Bharat Biotech, the World Health Oganisation on Wednesday approved its COVID-19 vaccine Covaxin.
According to news agency ANI, "Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that Covaxin vaccine meets WHO standards for protection against COVID, that benefit of the vaccine far outweighs risks and the vaccine can be used across the world."
The global health body also said, "Covaxin vaccine was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above."
However, WHO said that the available data on vaccination of pregnant women with the Covaxin are insufficient to assess vaccine safety or efficacy in pregnancy. "The studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry," the health body added.
The World Health Organization technical committee today met for a decision on giving an emergency use listing (EUL) to Covaxin, which amounted to a recognition and helped pave the way for people who have taken the dose to qualify for vaccine mandates in other countries.
Bharat Biotech had been stuck in a regulatory loop, with independent technical experts of the UN health body taking longer to analyse the data that previously disclosed timelines.
The TAG on October 26 had sought "additional clarifications" from the company for Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
The TAG-EUL is an independent advisory group that provides recommendations to WHO on whether a COVID-19 vaccine can be listed for emergency use under the EUL procedure.
Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant.
In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.
Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India.
(With agency inputs)
